Clinical trials of thermoplastic medical devices

Thermoplastic Mandibular Advancement Devices for the Treatment of OSAHS (obstructive sleep apnea-hypopnea syndrome)


Objective:1) Report our experience with custom-made and thermoplastic mandibular advancement devices (MADs). 2) Compare the cost, efficacy, and compliance of thermoplastic mandibular advancement devices vs custom made MADs.

Method: Retrospective review of 287 consecutive adult outpatients treated between July 2009 and August 2010. Compliance was assessed using chart review and phone interviews after 1 and 6 months. Endpoints included: 1. Efficacy measured by post-MAD AHI.

Results: The percentage of patients achieving AHI reduction criteria for efficacy was 70.3% and 72.2% for thermoplastic vs custom-made devices (P = .204). Compliance more than 4 hours a night for 70% of nights within the first month after receiving MAD was 88.2% for thermoplastic vs 64.3% for custom-made (P < .001). At 6 months compliance was 47.4% for thermoplastic devices vs 61.1% for custom devices (P = .01). The average cost for the thermoplastic devices was $150 vs $1450 for the custom-made devices.

Conclusion: Thermoplastic devices resulted in slightly better compliance rate compared with the custom-made devices during the first month after prescription, but reversed at 6 months. Thermoplastic devices have the advantage of significantly lower cost, higher initial acceptance, and comparable efficacy, whereas custom-made devices result in higher long-term compliance.

Original Publication

Otolaryngology office-based treatment of obstructive sleep apnea-hypopnea syndrome OSAHS with titratable and nontitratable thermoplastic mandibular advancement devices.
Department of Otolaryngology-Head and Neck Surgery, Rush University Medical Center, Chicago, IL 60602, USA.


Objective: 1) Share our experiences treating patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) with titratable and nontitratable thermoplastic mandibular advancement devices (MADs) fitted in our otolaryngology clinic. 2) Compare these devices in terms of objective response (OR), as defined by a > or = 50 percent decrease in baseline apnea-hypopnea index (AHI) and an AHI < 20, and subjective parameters, including adherence. 3) Determine overall success, as defined by OR plus adherence at two months follow-up.

Study design: Cohort study.

Setting: Tertiary care center.

Subjects and methods: Patients with OSAHS who tried and failed or refused both continuous positive airway pressure (CPAP) and surgical therapy were fitted with a nontitratable Snore Guard (n = 38), nontitratable SomnoGuard 2.0 (n = 8), or titratable SomnoGuard AP (n = 41). Pre- and post-treatment assessment included: 1) Epworth Sleepiness Scale, 2) snoring level, 3) polysomnogram. Patients were contacted at two months follow-up to assess adherence and subjective parameters.

Results: or was achieved in 62.1 percent of patients. Overall mean reduction in AHI was from 39.96 +/- 23.70 to 14.86 +/- 13.46 (P = 0.000). Adherence at two months was 58.5 percent. No significant differences were observed in OR or adherence according to MAD type, though improvements in AHI and minimum oxygen saturation were significantly better for the SomnoGuard AP than for the nontitratable devices. Overall success was 38.6 percent.

Conclusion: Thermoplastic MADs are a relatively inexpensive treatment alternative for patients with OSAHS who fail/refuse CPAP and upper airway surgery. They can be easily fitted in the otolaryngology clinic. Long-term compliance, efficacy, and safety are unknown at this time.
2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.

Original Publication

Important note: We do not take responsibility for any of the content you may find on these sites. If you have a personal health concern please consult your qualified health practitioner.